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Objective:To observe the TCM (Traditonal Chinese Medcine) syndromes effect and safety of Shujinjianyao Pill in the treatment of LSS (Lumbar Spinal Stenosis)(Ganshenbuzu and Fengshiyuzu Syndrome). Methods:120 LSS patients fit the inclusion criteria were separated into two groups,90 in the experimental group and 30 in the control group. No significant difference was existed in the basic data between the two groups. The experimental group was given Shujinjianyao Pill and Danlutongdu Tablet Simulator orally,while the control group was given Shujinjianyao Pill Simulator and Danlutongdu Tablet orally for 4 weeks. The VAS score,total TCM (Traditonal Chinese Medcine) syndrome score and single TCM symptom score on day 0,14 and 28 were observed,and adverse reactions were recorded. Result:There were significant differences in total TCM syndrome score between the two groups at baseline,14 day and 28 day (P < 0.01). There was a significant difference in total TCM syndrome score between the two groups at 28 day (P < 0.05). Significant differences were existed between this two groups in total effective rate of total TCM syndromes and waist-knee pain-weak in single TCM syndromes on the 28 day (P < 0.05). There was no significant difference in the incidence of adverse events and serious adverse events between the two groups (P > 0.05). Conclusion:Shujinjianyao Pill is effective on TCM syndromes in the treatment of Ganshenbuzu and fengshiyuzu syndrome LSS,especially in improving the score of total TCM syndromes and waist-knee pain-weak of single TCM syndrome,and has high safety.